NCT04633317

Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia

Aerosolized Colistin to Mechanical Ventilated Patients With CRGNB Pneumonia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chang Gung University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine the effect of aerosolized colistin on to ventilated patients with carbapenem-resistant gram negative bacteria pneumonia. We hypothesize that adjunct aerosolized colistin, which achieve high drug concentrations in the airway, would more effectively treat the penumbra.

Detailed description

To treat respiratory infection of patients with mechanical ventilation, greater systemic antibiotic dose is required through the patient's venous injection. In this trial, patients with arbapenem-resistant gram negative bacteria pneumonia (CRGNB)were assigned to adjunct aerosolized colistin delivered by a jet nebulizer or a vibrating mesh nebulizer comparing to or standard intravenous injection by a randomizing protocol. Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between standard care and study drug for their effects on bacteria eradiation, incidence of nephrotoxicity, and oxygenation.

Conditions

• Pneumonia, Bacterial

Interventions

Type	Name	Description
DEVICE	A pneumatic nebulizer	Inhaled colistimethate sodium generated by a pneumatic nebulizer
DEVICE	A vibrating mesh nebulizer	Inhaled colistimethate sodium generated by a vibrating mesh nebulizer

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2020-11-18
• Last updated: 2023-06-02

Locations

2 sites across 1 country: Taiwan